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Study of Volasertib and Belinostat in Patients With Relapsed and Refractory Aggressive B-cell and T-cell Lymphomas

NCT02875002 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-12-22

No results posted yet for this study

Summary

This phase 1, multicenter, open-label study is designed to find the RP2D of volasertib, a PLK1 inhibitor, and belinostat, an HDAC inhibitor, when given in combination to patients with relapsed or refractory B-cell or T-cell lymphoma. A standard 3+3 dose-escalation design will be employed with study enrollment beginning at dose level 1.

Conditions

  • Relapsed and Refractory Aggressive B- and T-cell Lymphomas
  • Lymphoma

Interventions

DRUG

volasertib

Volasertib (BI6727) is a small molecule inhibitor of the polo-like kinase 1 (PLK1) protein. Infusion for 60 minutes. Dosing will start at 25 mg/m\^2, is schedule to increase to 100mg/m\^2, and be administered on days 1 and 8 of each 28-day cycle.

DRUG

belinostat

Belinostat is a histone deacetylase inhibitor. Infusion will take 30 minutes. Dosing will start at 600 mg/m\^2 , is scheduled to increase to 1000 mg/m\^2, and will be administered on days 1,2,3 and 8,9,10 of each 28-day cycle.

Sponsors & Collaborators

  • Massey Cancer Center

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Steven Gore, MD · Yale University

  • Iris Isufi, MD · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-03-31
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875002 on ClinicalTrials.gov